Kelly Science & Clinical is seeking a Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.
Direct Hire
Shift: Monday - Friday 8am-5pm
Hybrid: 2 days remote, 3 days onsite
Compensation: based on experience
Responsibilities:
- Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.
- Assist in maintaining the Quality Management System to ensure domestic and international standards are met.
- Define and document corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies.
- Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.
- Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.
- Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and Technical Files.
- Provide technical assistance to other departments in the determination of testing requirements to comply with medical device and electrical safety regulations.
- Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.
- Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
- Review, analyze and approve validations as appropriate.
- Provide assistance interdepartmentally in the formal assessment of risk in accordance to published regulations and/or customer expectations.
- Strive for continuous improvements to the regulatory processes.
- Communicate regularly and effectively with cross-functional personnel in order to achieve desired objectives.
- Complete special projects as assigned by the Quality / Regulatory Manager.
- Adhere to and promote all organizational policies and procedures.
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in a science, mathematics, engineering or other technology field
- 5+ years of progressive experience in regulatory affairs required
- Appropriate combination of education and experience may also be acceptable
- Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required
- Experience with medical device products required
- Experience with EPA regulations required
- Experience with EU MDR Technical Documentation required
- Experience with 510(k) submissions required
- Experience with Health Canada License submissions and amendments required
- RAPS or other regulatory certifications required
- Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
- Problem solving/analysis including statistical process control
- Technical capacity including decision making, communication and reporting
- Strong interpersonal communication skill set
- Organizational skills